search
Back to results

Using Large-area Low-level Light Therapy for Treating Adhesive Capsulitis of the Shoulder

Primary Purpose

Adhesive Capsulitis of Shoulder

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Low-level laser therapy (LLLT)
Conventional physical therapy
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adhesive Capsulitis of Shoulder focused on measuring adhesive capsulitis, low-level laser therapy

Eligibility Criteria

40 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age between 40 to 85 years old Diagnosed with adhesive capsulitis clinically. Painful restriction of both active and passive flexion less than 120° and 50% restriction of the external rotation aside the body Visual analog scale of shoulder motion pain greater than 3 on a scale of 10 No fracture, dislocation, or arthritis in shoulder region Exclusion Criteria: History of or scheduled shoulder or chest surgery Significant shoulder trauma within the previous 2 years Presence of cervical radiculopathy or other central or peripheral neurologic deficits of the upper limb Known shoulder tendon tear or active tendinitis or bursitis as confirmed with US Contraindication of low-level light therapy Pregnancy, cancer, patient with pacemaker, high bleeding tendency, or longterm corticosteroid use. Poor consciousness state, or patients with sensory impairment Patients hypersensitive to light Severe circulatory system disorder

Sites / Locations

  • National Taiwan University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Treatment group (low-level laser therapy with conventional physical therapy)

Conventional group (conventional physical therapy only)

Arm Description

Low-level laser therapy three times a week, 10 minutes each time, for 8 weeks. Along with conventional physical therapy, three times a week, for 12 weeks.

Conventional physical therapy, three times a week, for 12 weeks.

Outcomes

Primary Outcome Measures

Shoulder range of motion
Shoulder flexion, abduction, external rotation, internal rotation
Shoulder pain score
Visual analogue scale for pain during shoulder motion (scale from 0 to 10, with higher scores mean worse outcome)

Secondary Outcome Measures

Functional evaluation
Shoulder Pain Disability Index (SPADI)
Ultrasound examination
Thickness of coracohumeral ligament and inferior glenohumeral capsule
Functional evaluation
Disability of the Arm, Shoulder, and Hand (DASH) questionnaire

Full Information

First Posted
July 16, 2023
Last Updated
August 16, 2023
Sponsor
National Taiwan University Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT06004609
Brief Title
Using Large-area Low-level Light Therapy for Treating Adhesive Capsulitis of the Shoulder
Official Title
Using Large-area Low-level Light Therapy for Treating Adhesive Capsulitis of the Shoulder
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 21, 2023 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

Brief Summary
Adhesive capsulitis, is a common problem characterized by the insidious onset of glenohumeral pain and limitation of shoulder motion in all planes. Clinically, frozen shoulder could be divided into freezing, frozen and thawing stage. The treatments of frozen shoulder are mainly conservative, including non-steroidal anti-inflammatory medications and physiotherapy. Due to debilitating pain at a certain stage and protracted clinical course, intra-articular corticosteroid injection in the early stages of idiopathic adhesive capsulitis has long been used to treat adhesive capsulitis with satisfactory result. However, intra-articular steroid injection still raise some controversy and is still considered too invasive for some patients. Low-level laser therapy (LLLT) is a safe and non-invasive alternative. LLLT can employ photo-biomodulation effects to help normalize cellular functions and is considered to have partial effect in many shoulder soft tissue disorders. Possible mechanisms include increasing adenosine triphosphate production, fibroblast activity and collagen synthesis. One prospective cohort study has shown that LLLT can be effective in the management of the early phase (less than 6 weeks of disease onset) of adhesive capsulitis of the shoulder in elderly who failed to respond to conventional physical therapy and nonsteroidal anti-inflammatory medications and improvement was found maintained up to 2 years. To this date, no randomized controlled study has been made to establish the possible role of LLLT as an adjuvant therapy on adhesive capsulitis. Also, no study has researched the effect of LLLT on patient with later stage/chronic phase of adhesive capsulitis. The objective of this paper is to report the clinical result of a study on the efficacy of LLLT as an add-on therapy in the management of adhesive capsulitis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adhesive Capsulitis of Shoulder
Keywords
adhesive capsulitis, low-level laser therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment group (low-level laser therapy with conventional physical therapy)
Arm Type
Experimental
Arm Description
Low-level laser therapy three times a week, 10 minutes each time, for 8 weeks. Along with conventional physical therapy, three times a week, for 12 weeks.
Arm Title
Conventional group (conventional physical therapy only)
Arm Type
Active Comparator
Arm Description
Conventional physical therapy, three times a week, for 12 weeks.
Intervention Type
Device
Intervention Name(s)
Low-level laser therapy (LLLT)
Intervention Description
Low-level laser therapy (LLLT), three time each week, 10 minutes each time, during the first 8 weeks of the treatment trial.
Intervention Type
Other
Intervention Name(s)
Conventional physical therapy
Intervention Description
Conventional physical therapy will be applied three time each week, for 12 weeks
Primary Outcome Measure Information:
Title
Shoulder range of motion
Description
Shoulder flexion, abduction, external rotation, internal rotation
Time Frame
24 weeks after enrollment
Title
Shoulder pain score
Description
Visual analogue scale for pain during shoulder motion (scale from 0 to 10, with higher scores mean worse outcome)
Time Frame
24 weeks after enrollment
Secondary Outcome Measure Information:
Title
Functional evaluation
Description
Shoulder Pain Disability Index (SPADI)
Time Frame
Immediate upon enrollment, and 8, 12, 24 weeks after enrollment
Title
Ultrasound examination
Description
Thickness of coracohumeral ligament and inferior glenohumeral capsule
Time Frame
Immediate upon enrollment, and 8, 12, 24 weeks after enrollment
Title
Functional evaluation
Description
Disability of the Arm, Shoulder, and Hand (DASH) questionnaire
Time Frame
Immediate upon enrollment, and 8, 12, 24 weeks after enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age between 40 to 85 years old Diagnosed with adhesive capsulitis clinically. Painful restriction of both active and passive flexion less than 120° and 50% restriction of the external rotation aside the body Visual analog scale of shoulder motion pain greater than 3 on a scale of 10 No fracture, dislocation, or arthritis in shoulder region Exclusion Criteria: History of or scheduled shoulder or chest surgery Significant shoulder trauma within the previous 2 years Presence of cervical radiculopathy or other central or peripheral neurologic deficits of the upper limb Known shoulder tendon tear or active tendinitis or bursitis as confirmed with US Contraindication of low-level light therapy Pregnancy, cancer, patient with pacemaker, high bleeding tendency, or longterm corticosteroid use. Poor consciousness state, or patients with sensory impairment Patients hypersensitive to light Severe circulatory system disorder
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chueh-Hung Wu, MD, PhD
Phone
+886-2312-3456
Ext
66473
Email
nojred@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
En Yang, MD
Phone
+886-2312-3456
Ext
52370
Email
youngforever0826@gmail.com
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chueh-Hung Wu, MD, PhD
Phone
+886-2312-3456
Ext
66473
Email
nojred@gmail.com
First Name & Middle Initial & Last Name & Degree
En Yang, MD
First Name & Middle Initial & Last Name & Degree
Ying-Chun Chen, MD
First Name & Middle Initial & Last Name & Degree
Hsing-Yu Chen

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Using Large-area Low-level Light Therapy for Treating Adhesive Capsulitis of the Shoulder

We'll reach out to this number within 24 hrs